Search Results

The Camber Sacroiliac (SI) Fixation System is intended for sacroiliac joint fusion for conditions including sacroliac joint disruptions and degenerative sacroiliitis.

The Camber SI Fixation System is comprised of a single-use implant and reusable instruments. The Camber SI Fixation System implant is intended to be implanted in the undeployed state via a posterior approach into the sacroiliac joint. Once implanted, the anchors are deployed to stabilize the sacroiliac joint. The Camber SI Fixation System implant includes multiple openings to allow surgeons to fill them with autogenous bone graft.

The provided text describes a Camber Sacroiliac (SI) Fixation System, a medical device for sacroiliac joint fusion. It details the regulatory clearance (K233972) and includes a "Performance Testing Summary."

However, this document does not contain any information about a study involving an AI/software device that requires acceptance criteria related to accuracy, sensitivity, specificity, or human reader performance.

The performance testing listed here relates to the mechanical and biological aspects of a physical implantable device (e.g., static vertical shear, dynamic vertical shear, expulsion, pin retaining, anchor strength, cadaver testing), not to the performance of an AI algorithm or a diagnostic software.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, specifically regarding AI performance, based on the provided text. The questions you've asked (about sample size, data provenance, experts, adjudication, MRMC studies, standalone performance, and ground truth for training/test sets) are all relevant to the validation of AI/software as a medical device, which is not the subject of this document.

Ask a specific question about this device